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Hit a Nerve? Obviousness Inquiry Must Address Claims at Issue

The US Court of Appeals for the Federal Circuit vacated and remanded a Patent Trial & Appeal Board non-obviousness decision, finding that the context of the proposed combination of prior art in the Board’s obviousness inquiry was not directed toward the context of the claim at issue. Axonics, Inc. v. Medtronic, Inc., Case No. 21-1451 (Fed Cir. July 10, 2023) (Lourie, Dyk, Taranto, JJ.)

Axonics filed petitions for inter partes review (IPR) challenging the validity of two patents owned by Medtronic as obvious. During the IPRs, the Board analyzed two prior art references, an article titled, “Electrical Stimulation of the Trigeminal Nerve Root for the Treatment of Chronic Facial Pain” by Ronald Young and a patent assigned to Gerber. The Medtronic patents described percutaneously positioning a lead to stimulate the sacral nerve. By contrast, Gerber described positioning an electrode in the sacral nerve region in a non-percutaneous way, and Young described positioning an electrode percutaneously to stimulate the trigeminal sensory root. The Board found that Medtronic’s patents were not obvious over Young in view of Gerber because of lack of motivation to combine the two prior art references. The Board also noted “that the proposed combination ‘would not be feasible in the trigeminal nerve region.’” Axonics appealed.

The Federal Circuit found that the Board erred in conducting the obviousness analysis. The Board’s proposed analysis centered on Young’s trigeminal sensory root context, not the Medtronic patents’ sacral nerve context. First, the Board questioned whether motivation to use the resulting combination of Young and Gerber existed in the trigeminal nerve context, but not in Medtronic patents’ sacral nerve context. Second, the Board found “that the relevant art [of the Medtronic patents] is medical leads specifically for sacral neuromodulation.”

Addressing the first error, the Federal Circuit explained that the prior art combination must be directed toward meeting the requirement of the claimed patent, not the requirement of the first prior art. The Court found that the Board did not conduct this analysis. Addressing the second error, the Court noted that “the relevant art” of the Medtronic patents was not “limited to medical leads for sacral-nerve stimulation.” The Court examined the specification of the patent as well as its claim and ruled that the scope of the Medtronic patents was broader than what the Board concluded.

The Court found that the Board’s errors were not harmless since the Board relied on these errors in rejecting Axonics’s obviousness arguments and provided no other reason for concluding Medtronic’s claims were not obvious. Therefore, the Court vacated the Board’s decision and remanded for further consideration.

Practice Note: In considering obviousness arguments under 35 U.S.C. § 103, keep in mind the difference between the claim at issue and the considered combination of prior art. The scope of the claim also needs to be considered based on the entirety of the patent.

Woohyeong Cho, a summer associate in the Washington, DC, office, also contributed to this case note.

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Disclaiming Claim Scope: Could the Patentee Have Anticipated This?

In the most recent decision in the Apple/VirnetX saga, the US Court of Appeals for the Federal Circuit affirmed a remand ruling from the Patent Trial & Appeal Board finding the challenged claims of VirnetX’s patents unpatentable. VirnetX Inc. v. Mangrove Partners Master Fund, Ltd., Case No. 2020-2271 (Fed. Cir. Mar. 30, 2023) (Moore, C.J.; Hughes, Stark, JJ.) (nonprecedential).

VirnetX owns two patents relating to a “secure mechanism for communicating over the internet.” The patents relate to a system in which a DNS module “intercepts . . . and determines whether [a] request is for a secure site.” The system creates a VPN if the proxy determines that the request is for a secure site. If the proxy determines that the request is not for a secure site, it forwards the request to a conventional DNS.

Mangrove, Apple and Black Swamp (collectively, Mangrove) petitioned for inter partes review (IPR) challenging various claims of the patents. The Board found that all the challenged claims were unpatentable as anticipated by Kiuchi or obvious in view of Kiuchi and other references. VirnetX appealed to the Federal Circuit (Mangrove Appeal). In that appeal, the Federal Circuit determined that, contrary to the Board’s finding, when VirnetX distinguished Aventail during reexamination of one of the patents, VirnetX disclaimed “a system in which a client computer communicates with an intermediate server via a singular, point-to-point connection.” As a consequence of the prosecution disclaimer, the Court found that the claims “require[s] direct communication between the client and target computers.” The Court vacated the Board’s decision and remanded the case for the Board to determine further factual questions regarding Kiuchi because “substantial evidence does not support the Board’s finding that the C-HTTP name server of Kiuchi performs the functions of the claimed DNS proxy module.”

Following the Mangrove Appeal, the Board again found that Kiuchi—the only prior art reference at issue in the present appeal—discloses a “secure network” for the transfer of patient information in a hospital setting and teaches a “direct-communication VPN between the client and target.” As a result, the Board concluded that Kiuchi anticipates all the challenged claims. VirnetX again appealed.

The Federal Circuit first addressed the Board’s conclusion that “Kiuchi teaches a direct-communication VPN and is therefore within the scope of the claims of VirnetX’s … patent, and not an indirect-communication VPN, which would have brought Kiuchi within the scope of VirnetX’s disclaimer.” The Court agreed with the Board that “Kiuchi discloses direct communication that satisfies the claimed VPN.” Specifically, “Kiuchi’s user agent does not communicate with the client-side proxy using a singular, point-to-point connection because the user agent addresses the desired endpoint, and the VPN provides the required message routing for the user agent to receive a response from the desired endpoint.” Moreover, the Court reasoned that Kiuchi’s proxy servers forward data packets and that Kiuchi teaches “the ability to address data to a particular computer,” consistent with the scope of the claims.

Next, the Federal Circuit addressed the Board’s [...]

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Design Patent Prior Art Must Be From Same or Analogous Field as Claimed Article of Manufacture

Finding that the Patent Trial & Appeal Board (Board) applied an erroneous interpretation of claim scope, the US Court of Appeals for the Federal Circuit reversed a Board decision upholding an examiner’s rejection of a lip implant design patent as anticipated by a non-analogous art tool. In re: SurgiSil, Case No. 20-1940 (Fed. Cir. Oct. 4, 2021) (Moore, C.J.)

SurgiSil filed a design application for a lip implant shaped like a generally cylindrical rod that tapered to a point at each end. The examiner rejected the patent as anticipated by a “stump,” an art tool of similar, almost identical, shape used for smoothing and blending areas of pastel or charcoal. SurgiSil appealed the rejection to the Board. The Board affirmed the rejection, finding that the differences in the shapes of SurgiSil’s lip implant and the art tool were minor. The Board rejected SurgiSil’s argument that the two articles of manufacture were “very different,” reasoning that it is irrelevant whether a prior art reference is analogous for anticipation purposes. SurgiSil appealed.

Reviewing the Board’s legal conclusions de novo, the Federal Circuit found that the Board erred as a matter of law. Citing 35 U.S.C. § 171(a) and the 1871 Supreme Court decision in Gorham Co. v. White, the Court explained that a design patent claim does not cover the design in the abstract, and that it is limited to the particular article of manufacture identified in the claim. The Court concluded that the claimed design was limited to a lip implant, did not cover other articles of manufacture and that the Board’s decision therefore rested on an erroneous interpretation of the claim’s scope.

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Knowledge of Patent, Evidence of Infringement Are Necessary, but Not Sufficient, to Establish Willfulness

Addressing claim construction, enablement, damages and willfulness, the US Court of Appeals for the Federal Circuit found that evidence of a defendant’s knowledge of the asserted patent and proof of infringement were, by themselves, legally insufficient to support a finding of willfulness. Bayer Healthcare LLC v. Baxalta Inc., Case No. 19-2418 (Fed. Cir. Mar. 1, 2021) (Stoll, J.)

Bayer owns a patent on certain recombinant forms of human factor VII (FVIII), a protein that is critical for blood coagulation. Recombinant FVIII is useful as a treatment for coagulation disorders, primarily Hemophilia A. Natural FVIII has a short half-life, making therapeutic administration expensive and inconvenient. Adding polyethylene glycol (a process known as PEGylating) to FVIII at random sites was found to increase the protein’s half-life but reduce its function. Bayer invented FVIII that is PEGylated in a specific region (the B-domain) so that it retains its function and maintains the longer half-life.

After Baxalta developed a PEGylated FVIII therapeutic, Adynovate®, Bayer sued Baxalta for infringement of its patent. During claim construction, the district court construed the claim preamble “an isolated polypeptide conjugate” to mean “a polypeptide conjugate where conjugation was not random,” finding that Bayer had disclaimed conjugates with random PEGylation. The district court also construed “at the B-domain” to mean “attachment at the B-domain such that the resulting conjugate retains functional FVIII activity,” rejecting Baxalta’s proposal of “at a site that is not any amine or carboxy site in FVIII and is in the B-domain” because Bayer had not disclaimed PEGylation at amine or carboxy sites. Before trial, Baxalta moved for clarification of the term “random” in the construction of the preamble, but the district court “again” rejected Baxalta’s argument that Bayer defined “random” conjugation as “any conjugation at amines or carboxy sites.”

Before trial, Baxalta moved to exclude the testimony of Bayer’s damages expert regarding his proposed reasonable-royalty rate. The expert had defined a bargaining range and proposed to testify that the royalty rate should be the midpoint of the range based on the Nash Bargaining Solution. The district court permitted the expert to testify as to the bargaining range but excluded the opinions regarding the midpoint as insufficiently tied to the facts of the case.

After trial, the district court granted Baxalta’s pre-verdict motion for judgment as a matter of law (JMOL) of no willful infringement. Subsequently, the jury returned a verdict that the claims were infringed and not invalid for non-enablement, and awarded damages based on an approximately 18% royalty rate for the period for which the parties had presented sales information. Baxalta moved for JMOL or a new trial on infringement, enablement and damages. Bayer moved for pre-verdict supplemental damages for the period between the presented sales data and the date of judgment, and for a new trial on the issue of willfulness. The district court denied all of Baxalta’s motions and Bayer’s motion for new trial, but granted Bayer’s motion for supplemental damages, applying the jury’s ~18% rate to sales data for the later period. [...]

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Garage Door Opener Dispute Highlights Importance of Disavowal

In a pair of opinions, the US Court of Appeals for the Federal Circuit addressed appeals arising out of the Chamberlain Group and One World Technologies’ patent infringement dispute concerning garage door opener technology. In the first appeal of a limited exclusion order issued by the USITC, the Federal Circuit reversed and vacated the USITC’s determination of infringement after finding that it was premised on an incorrect claim construction. Techtronic Industries Co. Ltd. v. Int’l Trade Comm’n, Case No. 18-2191 (Fed. Cir., Dec. 12, 2019) (Lourie, J.). In the second appeal, the Court held the PTAB’s finding that the challenged claims were anticipated was supported by substantial evidence. Chamberlain Group, Inc. v. One World Techs., Inc., Case No. 18-2112 (Fed. Cir., Dec. 17, 2019) (Hughes, J.).

The Chamberlain Group asserted various garage door opener technology patents against One World, including a patent directed to “an interactive learn mode” that assists users in installation and operation of a garage door opener.


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